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New Data Boosts Nanobiotix's Radiotherapy-Transformation Strategy

Nanobiotix gains more clinical evidence to support its nanoparticle technology in combination with radiotherapy to enhance treatment outcomes in cancer patients.

Cancer Innovation Research & Development

India's Caps On Cardiac Stent Pricing Angers Industry

India has brought cardiac stents under price controls after an advisory body to the health ministry contended there was “huge exploitation” of patients by the medical devices industry. The move drew strong criticism from industry which said the decision “does not bode well” for Prime Minister Narendra Modi’s stepped-up drive to attract foreign investment.

India Cardiovascular Commercial

FDA Panel Overwhelmingly Votes For Dexcom CGM to Replace Finger Sticks

The US FDA's Clinical Chemistry and Clinical Toxicology Devices Panel voted eight to two to recommend Dexcom's G5 Continuous Glucose Monitor to replace finger-stick testing in diabetic patients over the age of two. Also, a post-panel podcast chat with Dexcom's Steve Pacelli.

Diabetic Care Diagnostics Regulation

Welcome To Medtech Insight: The Gray Sheet, Clinica And More, All In One Place

Welcome to Medtech Insight, where you will find all the content from The Gray Sheet and Clinica, together with our medical device news and insight from Scrip Regulatory Affairs, Medtech Insight Newsletter and Start Up. Now you have an unparalleled source of information on the medical device and diagnostics sectors in one place.

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Policy & Regulation

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EU TTIP Device Proposals Rely Heavily on Device Regulators Forum

The European Commission circulated its device-regulation proposals as part of negotiations for the Transatlantic Trade and Investment Partnership with the US. It emphasized convergence of technical and clinical requirements and the important role of the International Medical Device Regulators Forum.

Regulation Europe United States

At The Intersection Of Quality And Metrics: What's Ahead In FDA’s Effort To More Objectively Measure Quality

Quality metrics are being developed by the US FDA to not only determine which medical device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. In-process metrics work by the Medical Device Innovation Consortium will be used as the agency comes up with its own robust set of measurements. Meanwhile, FDA is gearing up for a new pilot program targeting 10-20 device manufacturers that will submit quality data to the agency; MDIC explains how to calculate its three quality metrics; and quality officials from Baxter, J&J and Stryker weigh in.

Analysis Manufacturing Quality Manufacturing

Latest From Policy & Regulation

Transition Arrangements For IVDs Under New EU Regulation: How Much Longer Is CE Marking Valid?

Transitioning to the new EU IVD Regulation is going to require a major overhaul of processes and technical documents for IVD companies and also place heavy demands on EU notified bodies. So how long do those operating in the EU have to comply? And what is required in terms of governance? Some answers below.

Policy & Regulation Regulation

European Commission Revises Device Software Guidance But Is "Almost Silent" On Mobile Apps

The only notable changes in the revised EU guideline on standalone software used in healthcare settings is the addition of definitions for new terms like software, and input and output data.

Medical Device Regulatory

IMDRF Consults On Competence Requirements For Device Reviewers

The IMDRF has spelt out the basic skills and competences that device reviewers should possess, whether they work for regulatory authorities or designated conformity assessment bodies.

Policy & Regulation Medical Device

Commercial

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Former Acclarent Execs Convicted Of Misdemeanors In Off-Label Case

Two former executives from J&J's Acclarent division were found not guilty of felony charges but convicted on misdemeanor counts. Prior to being acquired by J&J, Acclarent allegedly marketed its Relieva Stratus sinus dilation device as a steroid-delivery system, even though the FDA had cleared the device only to deliver saline.

Legal Regulation Medical Device

Latest From Commercial

MED-EL Buys Otorix’ Non-Surgical Bone-Conduction Hearing Technology

The non-implantable bone-conduction system, which MED-EL hopes to launch next year, will complement the Austrian hearing technology company’s existing cochlear implants and other implantable hearing devices.

Commercial Deals

Device Week – July 22, 2016

On this week's podcast, Reed Miller talks about growing interest in robotics for spine surgery, and Tina Tan discusses the obesity device market.

Commercial Innovation

Earnings Winners And Losers: ABT, ISRG, STJ, SYK

Here are some of the highlights (and lowlights) from the second-quarter sales and earnings reports that medical device companies announced last week.

Commercial Companies

Clinical R&D

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Mazor’s Run Of Good News Continues With Trials Presented At IMAST

Data from 848 cases supports the clinical benefits of Renaissance robot-guided spine-surgery over comparable “freehand” minimally invasive procedures, according to the Israeli company.

Research & Development Clinical Trials Innovation

Latest From Research & Development

STARTS & STOPS: Cardiovascular And Neurology See Several Late-Stage Trial Starts

Starts & Stops is a regular feature highlighting the Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions from the previous month. Several big medtech players feature in June's selection of trial initiations, with a few emerging companies in the mix.

Clinical Trials Research & Development

OstomyCure’s TIES Titanium Ileostomy Device Launches In Europe

The Norwegian start-up announced the CE mark for its TIES ileostomy device, which will soon be implanted by gastro surgeons at select centers in Europe.

Research & Development Approvals

Novel Essential-Tremor Treatment Gets US Green Light

The ExAblate Neuro uses targeted ultrasound to destroy brain tissue linked to tremors. It is the first device of its type to gain approval from the US regulator.

Research & Development Approvals
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